Bone plates with dynamic elements

ABSTRACT

Bone fixation systems include various combinations of stabilizing members, dynamic elements, fasteners, and locking mechanisms. Bone plates receive dynamic bone staples and bone screws. Other dynamic elements include elbow pegs, straight pegs, and wire pegs.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.16/595,303, entitled “BONE PLATES WITH DYNAMIC ELEMENTS,” filed Oct. 7,2019, which is a continuation of U.S. application Ser. No. 16/368,794,entitled BONE PLATES WITH DYNAMIC ELEMENTS, filed Mar. 28, 2019, whichis a continuation of U.S. application Ser. No. 15/209,623, entitled BONEPLATES WITH DYNAMIC ELEMENTS, filed Jul. 13, 2016, which claims thebenefit of U.S. Provisional Application No. 62/192,059, entitled BONEPLATES WITH DYNAMIC ELEMENTS, filed Jul. 13, 2015. U.S. application Ser.No. 15/209,623 is also a continuation-in-part of International PatentApplication No. PCT/US2014/070495, entitled POLYAXIAL LOCKING HOLE,filed Dec. 16, 2014, which claims the benefit of U.S. ProvisionalApplication No. 61/919,069, entitled POLYAXIAL LOCKING HOLE, filed Dec.20, 2013. U.S. application Ser. No. 15/209,623 is also acontinuation-in-part of International Patent Application No.PCT/US2015/039551, entitled BONE IMPLANT AND MEANS OF INSERTION, filedJul. 8, 2015, which claims the benefit of U.S. Provisional ApplicationNo. 62/022,811, entitled BONE IMPLANT AND MEANS OF INSERTION, filed Jul.10, 2014. U.S. application Ser. No. 15/209,623 is also acontinuation-in-part of International Patent Application No.PCT/US2015/039556, entitled BONE IMPLANT WITH ANTI-ROTATION, filed Jul.8, 2015, which claims the benefit of U.S. Provisional Application No.62/022,811, entitled BONE IMPLANT AND MEANS OF INSERTION, filed Jul. 10,2014, and U.S. Provisional Application No. 62/036,240, entitled BONEIMPLANT WITH ANTI-ROTATION, filed on Aug. 12, 2014. The foregoing areincorporated by reference as though set forth herein in their entirety.

TECHNICAL FIELD

The present disclosure relates to plates having dynamic elements,otherwise known as elastic elements. Plates with dynamic elements may beused to stabilize and apply continuous load to hard tissues such asbone, or to soft tissues such as cartilage or ligaments. The presentdisclosure relates to plates with dynamic elements that providecontinuous load across a joint, a resection, an osteotomy, a fracture, atear, a laceration, or some other discontinuity between hard or softtissue portions. The continuous load may be compressive or tensile. Thepresent disclosure is made in the context of bone plates for use in thefoot, having various dynamic elements including staples, elbow pegs orL-pegs, and straight pegs. However, the principles disclosed herein areapplicable in locations throughout the body.

BACKGROUND

There are many circumstances in which bones, bone fragments, or othertissue portions must be fused together, united, or otherwise permanentlyjoined. Some examples include arthrodesis, corrective osteotomy,fracture, tear, or laceration. Bones, bone fragments, or other tissueportions heal better when they are stabilized with some mechanical loador stress across the discontinuity, for example when the bones, bonefragments, or other tissue portions are compressed together ordistracted apart. This disclosure describes solutions to the problem ofstabilizing bones, bone fragments, or other tissue portions whileapplying a therapeutic level of continuous mechanical load or stressacross the discontinuity.

SUMMARY

The various systems and methods of the present technology have beendeveloped in response to the present state of the art, and inparticular, in response to the problems and needs in the art that havenot yet been fully solved by currently available fixation systems. Thesystems and methods of the present technology may provide a means fordynamic loading while providing an overall stable construct.

To achieve the foregoing, and in accordance with the technology asembodied and broadly described herein, plate members providestabilization and/or deformity correction in conjunction with dynamicelements that provide continuous dynamic load between tissue portions.The plate members may or may not be used with the dynamic elements. Thedynamic elements may be separate parts that may be attached to the platemembers, or they may be integrally formed with the plate members. Theplate members and the dynamic elements may be made from the samematerials or from different materials. The dynamic elements may be madefrom any elastic material, preferably a highly elastic metal, preferablya superelastic metal, preferably nitinol.

These and other features and advantages of the present technology willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the technology as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the technology will become more fully apparentfrom the following description and appended claims, taken in conjunctionwith the accompanying drawings. Understanding that these drawings depictonly exemplary embodiments and are, therefore, not to be consideredlimiting of the scope of the technology, the exemplary embodiments willbe described with additional specificity and detail through use of theaccompanying drawings in which:

FIG. 1A is an oblique view of an assembly with a bone plate, a staple,and screws; FIG. 1B is another oblique view of the assembly of FIG. 1Afrom a different direction; FIG. 1C is a side view of the assembly ofFIG. 1A; FIG. 1D is a longitudinal cross-section of the assembly of FIG.1A along a mid-sagittal plane of the bone plate; FIG. 1E is an explodedoblique view of the assembly of FIG. 1A; and FIG. 1F is another explodedoblique view of the assembly of FIG. 1A from a different direction.

FIG. 2 is an oblique view of an assembly with the bone plate of FIG. 1Aand screws.

FIG. 3A is an oblique view of an assembly with a bone plate, a staple,and a set screw; FIG. 3B is another oblique view of the assembly of FIG.3A from a different direction; FIG. 3C is a side view of the assembly ofFIG. 3A; FIG. 3D is a longitudinal cross-section of the assembly of FIG.3A along a mid-sagittal plane of the bone plate; FIG. 3E is an explodedoblique view of the assembly of FIG. 3A; and FIG. 3F is another explodedoblique view of the assembly of FIG. 3A from a different direction.

FIG. 4A is an oblique view of an assembly with a bone plate and astaple; FIG. 4B is another oblique view of the assembly of FIG. 4A froma different direction; FIG. 4C is an exploded oblique view of theassembly of FIG. 4A; FIG. 4D is another exploded oblique view of theassembly of FIG. 4A from a different direction; FIG. 4E is yet anotheroblique view of the assembly of FIG. 4A, showing a tab in a closedconfiguration; FIG. 4F is a side view of the assembly of FIG. 4E; andFIG. 4G is a longitudinal cross-section of the assembly of FIG. 4E alonga mid-sagittal plane of the bone plate.

FIG. 5A is an oblique view of an assembly with a bone plate and a stapleinsert molded within the bone plate; FIG. 5B is another oblique view ofthe assembly of FIG. 5A from a different direction; FIG. 5C is a sideview of the assembly of FIG. 5A; FIG. 5D is a longitudinal cross-sectionof the assembly of FIG. 5A along a mid-sagittal plane of the bone plate;FIG. 5E is an exploded oblique view of the assembly of FIG. 5A; and FIG.5F is another exploded oblique view of the assembly of FIG. 5A from adifferent direction.

FIG. 6A is an oblique view of an assembly with a bone plate, elbow pegs,and screws; FIG. 6B is another oblique view of the assembly of FIG. 6Afrom a different direction; FIG. 6C is a side view of the assembly ofFIG. 6A; FIG. 6D is a longitudinal cross-section of the assembly of FIG.6A along a mid-sagittal plane of the bone plate; FIG. 6E is an explodedoblique view of the assembly of FIG. 6A; and FIG. 6F is another explodedoblique view of the assembly of FIG. 6A from a different direction.

FIG. 7A is an oblique view of an assembly with a bone plate, elbow pegs,and set screws; FIG. 7B is another oblique view of the assembly of FIG.7A from a different direction; FIG. 7C is a side view of the assembly ofFIG. 7A; FIG. 7D is a longitudinal cross-section of the assembly of FIG.7A along a mid-sagittal plane of the bone plate, showing one of theelbow pegs in an insertion configuration and another one of the elbowpegs in a final configuration; FIG. 7E is an exploded oblique view ofthe assembly of FIG. 7A; and FIG. 7F is another exploded oblique view ofthe assembly of FIG. 7A from a different direction.

FIG. 8A is an oblique view of an assembly with a bone plate, straightpegs, and set screws; FIG. 8B is another oblique view of the assembly ofFIG. 8A from a different direction; FIG. 8C is a side view of theassembly of FIG. 8A; FIG. 8D is a longitudinal cross-section of aportion of the assembly of FIG. 8A along a mid-sagittal plane of thebone plate, showing one of the straight pegs in an insertionconfiguration; FIG. 8E is a longitudinal cross-section of a portion ofthe assembly of FIG. 8A along a mid-sagittal plane of the bone plate,showing another one of the straight pegs in a final configuration; FIG.8F is an exploded oblique view of the assembly of FIG. 8A; and FIG. 8Gis another exploded oblique view of the assembly of FIG. 8A from adifferent direction.

FIG. 9A is a lateral oblique view of the bones of a human right foot;and FIG. 9B is a medial view of the bones of a human right foot.

FIG. 10 is an oblique view of a kit of bone plates.

FIG. 11 is another oblique view of the bone plate of FIG. 1A.

FIG. 12A is an oblique view of the screws of FIG. 1A; and FIG. 12B is aside view of the screws of FIG. 1A.

FIG. 13A is an oblique cross-section detail view of the non-lockingscrew of FIG. 1A in a hole of the bone plate of FIG. 1A; and FIG. 13B isan oblique cross-section detail view of the locking screw of FIG. 1A ina hole of the bone plate of FIG. 1A.

FIG. 14 is an oblique view of a kit of surgical instruments.

FIG. 15 is an oblique view of a sizing template of the kit of FIG. 14.

FIG. 16A is an oblique detail view of a plate of FIG. 10 with twobenders of the kit of FIG. 14; and FIG. 16B is an oblique detail view ofthe plate and a bender of FIG. 16A.

FIG. 17A is an oblique detail view of the plate and benders of FIG. 16A;FIG. 17B is an oblique detail view of the plate and bender of FIG. 16B,with an additional bender; and FIG. 17C is an oblique detail view of theplate and benders of FIG. 17B.

FIG. 18 is a medial oblique view of some of the bones of a human leftfoot, a bone plate, and a threaded drill guide of the kit of FIG. 14which doubles as a plate inserter tool. FIG. 18 shows the step ofinserting the bone plate.

FIG. 19A is a detail view of a portion of the threaded drill guide ofFIG. 18; and FIG. 19B is a medial oblique view of some of the bones of ahuman left foot, the bone plate of FIG. 18, two threaded drill guides ofFIG. 18, and an olive wire of the kit of FIG. 14. FIG. 19B shows thestep of drilling for a locking screw.

FIG. 20A is an oblique view of a non-locking polyaxial drill guide ofthe kit of FIG. 14 and a threaded plate bender of the kit of FIG. 14which doubles as a handle for the non-locking polyaxial drill guide; andFIG. 20B is a medial oblique view of some of the bones of a human leftfoot, the bone plate and threaded drill guide of FIG. 18, and thenon-locking polyaxial drill guide with threaded plate bender of FIG.20A. FIG. 20B shows the step of drilling for a non-locking screw.

FIG. 21 is a medial oblique view of some of the bones of a human leftfoot, the bone plate and threaded drill guide of FIG. 18, the screw ofFIG. 1A, and a screw driver of the kit of FIG. 14. FIG. 21 shows thestep of driving a locking screw.

FIG. 22A is a medial oblique view of some of the bones of a human leftfoot, the bone plate of FIG. 18, the screws of FIG. 1A, and a stapledrill guide of the kit of FIG. 14; FIG. 22B is a medial oblique view ofsome of the bones of a human left foot, the bone plate of FIG. 18, thescrews of FIG. 1A, and a staple inserter of the kit of FIG. 14; and FIG.22C is a medial oblique view of some of the bones of a human left foot,the bone plate of FIG. 18, the screws of FIG. 1A, and a staple.

FIG. 23 is a medial oblique view of some of the bones of a human leftfoot, the bone plate of FIG. 18, the screws of FIG. 1A, and a staple.

FIG. 24A is an oblique view of an assembly with a bone plate andstraight threaded pegs; FIG. 24B is another oblique view of the assemblyof FIG. 24A from a different direction; FIG. 24C is a side view of theassembly of FIG. 24A; FIG. 24D is a longitudinal cross-section of aportion of the assembly of FIG. 24A along a mid-sagittal plane of thebone plate; FIG. 24E is an oblique view of a portion of a straight peginserter instrument; FIG. 24F is an oblique view of the assembly of FIG.24A with the inserter instrument of FIG. 24E, with one straight pegpartially inserted; FIG. 24G is another oblique view of the assembly ofFIG. 24A with the inserter instrument of FIG. 24E, with both straightpegs fully inserted; FIG. 24H is a cross sectional view of a portion ofthe components of FIG. 24G; FIG. 241 is an exploded oblique view of theassembly of FIG. 24A; and FIG. 24J is another exploded oblique view ofthe assembly of FIG. 24A from a different direction.

FIG. 25A is an oblique view of an assembly with a bone plate, wire pegs,and set screws; FIG. 25B is another oblique view of the assembly of FIG.25A from a different direction; FIG. 25C is a side view of the assemblyof FIG. 25A; FIG. 25D is a longitudinal cross-section of a portion ofthe assembly of FIG. 25A along a mid-sagittal plane of the bone plate;FIG. 25E is an oblique view of the wire peg of FIG. 25A in a free state;FIG. 25F is a cross sectional view of a portion of the assembly of FIG.25A, with a wire peg in a free state; FIG. 25G is an exploded obliqueview of the assembly of FIG. 25A; and FIG. 25H is another explodedoblique view of the assembly of FIG. 25A from a different direction.

FIG. 26A is an oblique view of an assembly with a bone plate, wire pegs,and set screws; FIG. 26B is another oblique view of the assembly of FIG.26A from a different direction; FIG. 26C is a side view of the assemblyof FIG. 26A; FIG. 26D is a longitudinal cross-section of a portion ofthe assembly of FIG. 26A along a mid-sagittal plane of the bone plate;FIG. 26E is an oblique view of the wire peg of FIG. 26A in a free state;FIG. 26F is a cross sectional view of a portion of the assembly of FIG.26A, with a wire peg in a free state; FIG. 26G is an exploded obliqueview of the assembly of FIG. 26A; and FIG. 26H is another explodedoblique view of the assembly of FIG. 26A from a different direction.

FIG. 27A is an oblique view of a wire peg in a free state; and FIG. 27Bis a side view of the wire peg of FIG. 27A.

FIG. 28A is an oblique view of an assembly with a bone plate, staples,and screws; FIG. 28B is another oblique view of the assembly of FIG. 28Afrom a different direction; FIG. 28C is a side view of the assembly ofFIG. 28A; FIG. 28D is a longitudinal cross-section of the assembly ofFIG. 28A along a mid-sagittal plane of the bone plate; FIG. 28E is anexploded oblique view of the assembly of FIG. 28A; and FIG. 28F isanother exploded oblique view of the assembly of FIG. 28A from adifferent direction.

DETAILED DESCRIPTION

Exemplary embodiments of the technology will be best understood byreference to the drawings, wherein like parts are designated by likenumerals throughout. It will be readily understood that the componentsof the technology, as generally described and illustrated in the figuresherein, could be arranged and designed in a wide variety of differentconfigurations. Thus, the following more detailed description of theembodiments of the apparatus, system, and method is not intended tolimit the scope of the invention, as claimed, but is merelyrepresentative of exemplary embodiments of the technology

The phrases “connected to,” “coupled to” and “in communication with”refer to any form of interaction between two or more entities, includingmechanical, electrical, magnetic, electromagnetic, fluid, and thermalinteraction. Two components may be functionally coupled to each othereven though they are not in direct contact with each other. The term“abutting” refers to items that are in direct physical contact with eachother, although the items may not necessarily be attached together. Thephrase “fluid communication” refers to two features that are connectedsuch that a fluid within one feature is able to pass into the otherfeature

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments. While the various aspects of theembodiments are presented in drawings, the drawings are not necessarilydrawn to scale unless specifically indicated.

Standard medical planes of reference and descriptive terminology areemployed in this specification. A sagittal plane divides a body intoright and left portions. A mid-sagittal plane divides the body intobilaterally symmetric right and left halves. A coronal plane divides abody into anterior and posterior portions. A transverse plane divides abody into superior and inferior portions. Anterior means toward thefront of the body. Posterior means toward the back of the body. Superiormeans toward the head. Inferior means toward the feet. Medial meanstoward the midline of the body. Lateral means away from the midline ofthe body. Axial means toward a central axis of the body. Abaxial meansaway from a central axis of the body. Ipsilateral means on the same sideof the body. Contralateral means on the opposite side of the body. Thesedescriptive terms may be applied to an animate or inanimate body.

In this specification, an elastically deformed state is defined asdeformation equivalent to strain values above 0.2%, for example strainvalues between 0.2% and 6%. An elastically deformed state is distinctfrom the small magnitude of deformation and strain tolerated by mostmaterials under load

In this specification, a static material, or a static design, or astatic component, is defined as a material, design, or component thattolerates deformation equivalent to no more than 0.2% strain beforeexperiencing permanent plastic deformation, bending, cracking, breaking,or other failure mode

Referring to FIGS. 1A-1F, an assembly 100 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 100,the stabilizing member may be a bone plate 102, the dynamic element maybe a staple 104, and the fasteners may be screws. Assembly 100 isillustrated with locking screws 106 on the left and non-locking screws108 on the right.

The bone plate 102 has an obverse side 112 and a reverse side 114. Whenthe bone plate 102 is implanted, the obverse side 112 faces away fromthe bone portions and the reverse side 114 faces toward the boneportions. The bone plate 102 includes several holes 116 which extendthrough the obverse and reverse sides 112, 114. Six holes 116 areillustrated, although any number of holes may be present. Each hole 116includes an internally threaded portion 118 and a non-threaded portion120 so that each hole 116 accepts either the locking screw 106 or thenon-locking screw 108. See FIGS. 13A and 13B. The internally threadedportion 118 engages external threads 119 on the head 107 of the lockingscrew 106. The internally threaded portion 118 may be adjacent to thereverse side 114. The non-threaded portion 120 engages the head 109 ofthe non-locking screw 108. The non-threaded portion 120 may be adjacentto the obverse side 112. The non-threaded portion 120 may be concaveand/or elongated. An optional groove 122 in the obverse side 112 extendsbetween two of the holes 116. Each of these two holes 116 is alsoelongated toward the other hole 116, leaving a web 124 extending betweenthe two holes 116. The web 124 may be adjacent to the reverse side 114.The web 124 separates the two holes 116, and may be present even if theholes 116 are not elongated towards each other. The optional groove 122if present, the two elongated holes 116, and the web 124 are referred tocollectively as a receiver 126, and the involved holes 116 are referredto as receiver holes 128. A receiver 126 may be included between any twoholes through a bone plate. Multiple receivers 126 may be included on asingle bone plate. For example, referring to FIGS. 1A and 1E, the boneplate 102 may be modified to include a second receiver between the lefttwo holes 116 and/or a third receiver between the right two holes 116.Two receivers 126 may share a common receiver hole 128. The bone plate102 may be much more stiff than the dynamic element, which in thisexample is the staple 104. The bone plate 102 may be rigid, or static asdefined above. Alternatively, the bone plate 102 may be malleable orelastic. The bone plate 102 may include rigid and malleable regions. Theillustrated bone plate 102 may be 2 mm thick in the vicinity of thereceiver 126 and 1.5 mm thick in the vicinity of the leftmost two holes116 and the rightmost two holes 116. The bone plate 102 may accommodatea staple 104 that is 18 mm×14 mm. The bone plate 102 is also illustratedin FIG. 11.

Referring to FIG. 10, several different bone plate shapes may beprovided in a kit or a set. FIG. 10 shows, from left to right, a leftdouble Y plate 102, a left Y plate, a right Y plate 902, a straight4-hole plate, and a straight 5-hole plate. A kit or set may also includea left metatarsophalangeal plate with 10 degree varus and zero degreedorsiflexion (not shown), and a right metatarsophalangeal plate with 10degree varus and zero degree dorsiflexion (not shown).

The staple 104 is described in at least one of the patent applicationsidentified in paragraph [0001] of this application. The staple 104 maybe the implant 200 of FIGS. 11 and 12, implant 300 of FIGS. 15A-16B,implant 600 of FIGS. 21 and 22, implant 800 of FIGS. 23A-24, or implant2200 of FIGS. 78 and 79 of International Patent Application Serial No.PCT/US2015/039551; or implant 100 of FIGS. 1-3, staple 300 of FIGS. 4and 5, staple 400 of FIG. 7, staple 480 of FIG. 8, or implant 2100 ofFIGS. 10A and 10B of International Patent Application Serial No.PCT/US2015/039556.

The staple 104 includes a body 140 or bridge, a first leg 142, and asecond leg 144. The bridge extends between a first end 146 and a secondend 148. The first leg 142 is coupled to the first end 146 andterminates in a first free end 143. The second leg 144 extends from thesecond end 148 and terminates in a second free end 145.

The staple 104 has an insertion state, or elastically deformed state,which is its shape under the influence of an external force, forexample, an external force applied by a staple inserter tool. A firstdistance separates the free ends 143, 145 in the elastically deformedstate. The staple 104 also has a free state, or relaxed state, which isits shape when no external forces are acting upon the staple, other thangravity. A second distance separates the free ends 143, 145 in therelaxed state. The second distance is different from the first distance.In the example shown, the legs 142, 144 of the staple 104 are parallelto one another in the elastically deformed state. However, the legs 142,144 may converge or diverge in the elastically deformed state. In theexample shown, the legs 142, 144 of the staple converge at their freeends, or tips, in the relaxed state, so that the second distance is lessthan the first distance. However, the legs 142, 144 may diverge at theirfree ends, or the legs 142, 144 may be parallel in the relaxed state.The staple 104 assumes the elastically deformed state under theinfluence of an external force. The staple 104 may resume the free stateas soon as the external force is removed. If the legs 142, 144 of thestaple 104 are engaged in bone holes, then the staple may only be ableto partially relax toward the free state due to the resistance of thebone. In this situation, the staple 104 may be in a loaded state inbetween the elastically deformed state and the relaxed state. The loadedstate of the staple is shown in FIGS. 1A-1F. The staple 104 ispreferably made of a superelastic alloy such as nitinol, although othermaterials are also suitable. In this example, the staple 104 is notlocked to the bone plate 102, although in subsequent examples the stapleis locked to the bone plate. In this example, the body 140 of the staple104 rests within the groove 122 of the receiver 126 against the web 124,and the staple legs 142, 144 extend through the receiver holes 128 andprotrude from the reverse side 114 of the bone plate 102. The web 124prevents the body 140 from passing through the reverse side 114 of thebone plate 102. The receiver 126 holds the staple 104 in a predeterminedorientation and relative position with respect to the bone plate 102.The receiver 126 is one example of a group of features that functiontogether to hold a staple a in a predetermined orientation and relativeposition with respect to a bone plate. Different features, or groups offeatures, may provide the same function. For example, the groove 122 maybe lacking so that the body 140 of the staple 104 rests atop the obverseside 112 of the bone plate 102, or the web 124 may be replaced by ledgesor other supports to serve as a stop or a docking point to prevent thebody 140 from passing through the reverse side 114. Furthermore, the web124 may be replaced by one or more stop feature(s) or docking feature(s)on the staple 104 instead of on the bone plate 102.

The locking screw 106 locks securely to any hole 116 in the bone plate102. The locking screw 106 may include an externally threaded head 107which locks to the hole 116 in the bone plate 102 when threaded tightlyinto the internally threaded portion 118 of the hole 116. The lockingscrew 106 may be the design disclosed in at least one of the patentapplications identified in paragraph [0001] of this application. Thelocking screw 106 may be the bone fixation device 390 of FIG. 11, bonefixation device 500 of FIGS. 24-26, bone fixation device 600 of FIGS.27-30 of International Patent Application Serial No. PCT/US2014/070495.The locking screw may have a 3.0 mm diameter and lengths from 8 mm to 30mm in 2 mm increments. The locking screw 106 is also illustrated in FIG.12.

The non-locking screw 108 does not lock to the holes 116 in the boneplate 102. Instead, it remains free to rotate and translate within theconfines of the screw hole 116 after implantation. The non-locking screw108 may be polyaxially positionable relative to the screw hole 116. Thenon-locking screw 108 may include a head 109 with an exterior surfacethat forms a ball -and-socket joint with the non-threaded portion 120 ofthe hole 116. The exterior surface may be convex, spherical, or conical.The non-locking screw 108 may have a 3.5 mm diameter and lengths from 8mm to 30 mm in 2 mm increments. The non-locking screw 108 is alsoillustrated in FIG. 12.

Referring to FIG. 13, the screws 106 and 108 are interchangeable in thescrew holes 116 of the bone plate 102.

Referring to FIG. 2, an assembly 200 may include a stabilizing memberand one or more fasteners. In assembly 200, the stabilizing member maybe the bone plate 102 and the fasteners may include one or more of thescrews 106 and/or 108. This example includes a locking screw 106 in oneof the receiver holes, showing that the screws 106 or 108 can be usedinterchangeably in the receiver holes 128 as well as the other holes 116of the bone plate 102.

Referring to FIGS. 3A-3F, an assembly 300 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 300,the stabilizing member may be a bone plate 302, the dynamic element maybe the staple 104, and the fasteners may include a set screw 310 and oneor more of the screws 106 and/or 108, although the screws 106 and 108are omitted from the illustration for clarity.

The bone plate 302 has an obverse side 312 and a reverse side 314. Thebone plate 302 includes several holes 316, each of which may include aninternally threaded portion 318 and a non-threaded portion 320, the sameas hole 116. The internally threaded portion 318 may be adjacent to thereverse side 314 and the non-threaded portion 320 may be adjacent to theobverse side 312. An optional groove 322 in the obverse side 312 extendsbetween two of the holes 316. Each of these two holes 316 is alsoelongated toward the other hole 316, leaving a web 324 extending betweenthe two holes 316. The web 324 may be adjacent to the reverse side 314.The web 324 separates the two holes 316, and may be present even if theholes 316 are not elongated towards each other. The web 324 prevents thebody 140 from passing through the reverse side 314. The optional groove322 if present, the two elongated holes 316, and the web 324 arereferred to collectively as a receiver 326, and the involved holes 316are referred to as receiver holes 328. The bone plate 302 includes aninternally threaded socket 338 which receives the set screw 310 inthreaded engagement. The set screw 310 locks the staple 104 to the boneplate 302, and may be referred to as a locking mechanism.

Referring to FIGS. 4A-4G, an assembly 400 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 400,the stabilizing member may be a bone plate 402, the dynamic element maybe the staple 104, and the fasteners may include one or more of thescrews 106 and/or 108, although the screws 106 and 108 are omitted fromthe illustration for clarity.

The bone plate 402 has an obverse side 412 and a reverse side 414. Thebone plate 402 includes several holes 416, each of which may include aninternally threaded portion 418 and a non-threaded portion 420, the sameas hole 116. The internally threaded portion 418 may be adjacent to thereverse side 414 and the non-threaded portion 420 may be adjacent to theobverse side 412. An optional groove 422 in the obverse side 412 extendsbetween two of the holes 416. Each of these two holes 416 is alsoelongated toward the other hole 416, leaving a web 424 extending betweenthe two holes 416. The web 424 may be adjacent to the reverse side 414.The web 424 separates the two holes 416, and may be present even if theholes 416 are not elongated towards each other. The web 424 prevents thebody 140 from passing through the reverse side 414. The optional groove422 if present, the two elongated holes 416, and the web 424 arereferred to collectively as a receiver 426, and the involved holes 416are referred to as receiver holes 428. The bone plate 402 includes aductile tab 430 that extends from the obverse side 412 beside thereceiver 426. There may be more than one tab 430. The tab 430 couplesthe staple 104 to the bone plate 402. The tab 430 may therefore beconsidered one of the fasteners, and may be referred to as a lockingmechanism. The tab 430 is illustrated in an open state in FIGS. 4A-4D,and in a closed state in FIGS. 4E-4G. In the open state, the staple 104may be inserted into the receiver 426. In the closed state, the tab 430prevents the staple 104 from being removed from the receiver. The tab430 may be bent over the staple 104 in the closed state. The tab 430 mayexperience plastic deformation, also known as permanent deformation, sothat the tab 430 remains bent over the staple 104 unless bent backtowards the open state. The tab 430 may be closed intraoperatively, orthe assembly 400 may be provided coupled together with the tab 430closed as shown in FIGS. 4E-4G.

Other means for locking the staple 104 to a bone plate are contemplated,such as a snap fit between the staple 104 and the bone plate (notshown).

Referring to FIGS. 5A-5F, an assembly 500 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 500,the stabilizing member may be a bone plate 502, the dynamic element maybe the staple 104, and the fasteners may be one or more of the screws106 and/or 108, although the screws 106 and 108 are omitted from theillustration for clarity.

The bone plate 502 has an obverse side 512 and a reverse side 514. Thebone plate 502 includes several holes 516, each of which may include aninternally threaded portion 518 and a non-threaded portion 520, the sameas hole 116. The internally threaded portion 518 may be adjacent to thereverse side 514 and the non-threaded portion 520 may be adjacent to theobverse side 512. Two of the holes 516 are elongated toward each other,leaving a web 524 extending between the two holes 516. The two elongatedholes 516 in this example lack the internally threaded portion 518. Theweb 524 may be adjacent to the reverse side 514. The web 524 separatesthe two holes 516, and may be present even if the holes 516 are notelongated towards each other. The web 524 prevents the body 140 frompassing through the reverse side 514. The two elongated holes 516 andweb 524 are referred to collectively as a receiver 526, and the involvedholes 516 are referred to as receiver holes 528. In this example, thebone plate 502 is formed around the staple 104 at least partially sothat the staple 104 is inseparable from the bone plate 502 in normaluse. The web 524 encircles a middle portion of the body 140 of thestaple 104, leaving lateral portions of the staple body 140 and thestaple legs 142, 144 free to flex between the relaxed state and theelastically deformed state. Alternately, the staple 104 may be partiallyor fully encapsulated in an elastically deformable material that bendswith the staple as the staple moves between the relaxed state and theelastically deformed state. The bone plate 502 may be made ofpolyetheretherketone (PEEK) which is overmolded around the staple 104.The staple 104 may be insert molded into the bone plate 502. The boneplate 502 and staple 104 may be integrally formed of a single material,preferably a highly elastic material such as nitinol. The stapleincluded in assembly 500 may be a modified version of staple 104. Themodifications may facilitate manufacturing the bone plate 502 and thestaple as a unit.

Referring to FIGS. 6A-6F, an assembly 600 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 600,the stabilizing member may be a bone plate 602, the dynamic element maybe an elbow peg 604 also known as an L-peg, and the fasteners may be oneor more of the screws 106 and/or 108.

The bone plate 602 has an obverse side 612 and a reverse side 614. Thebone plate 602 includes several holes 616. The holes 616 may lack aninternally threaded portion like hole 116. A groove 622 in the obverseside 612 extends between two of the holes 616 and within the holes,forming a shelf 623 within each hole 616. The shelf 623 may be adjacentto the reverse side 614. Each of these two holes 616 is also elongatedtoward the other hole 616, leaving a web 624 extending between the twoholes 616. The web 624 may be adjacent to the reverse side 614. The web624 separates the two holes 616, and may be present even if the holes616 are not elongated towards each other. The groove 622, two elongatedholes 616, and web 624 are referred to collectively as a receiver 626,and the holes 616 are referred to as receiver holes 628, since thesefeatures receive the elbow pegs 604.

Two elbow pegs 604 are shown facing each other in the assembly 600. Inthis example, the elbow pegs 604 take the place of the previous dynamicelement, the staple 104. Each elbow peg 604 includes a head 632 and abone-contacting leg 634, which terminates in a free end 635. The head632 may be shaped like a ring, as illustrated, or it may be any shape,such as rectangular, square, oval, polygonal, etc. The head 632 may beperpendicular, or nearly perpendicular, to the leg 634. For example, thehead 632 and the leg 634 may form an angle of 90 degrees±10 degrees, 90degrees ±15 degrees, or 90 degrees ±20 degrees. Alternatively, the head632 may form an acute angle or an obtuse angle with the leg 634. Eachelbow peg 604 may be independently inserted into a bone hole and securedto the bone plate 602. The elbow peg 604 may be secured to the boneplate 602 by a bone screw, such as screw 106 or 108, through an aperture636 through the head 632. The shelf 623 prevents the head 632 frompassing through the reverse side 614 of the bone plate 602. The elbowpeg 604 may develop some spring force as the bone screw is fully seated,as explained more fully below with regard to assembly 700. The springforce may be linear or nonlinear. The elbow peg 604 may exert force dueto simple leverage without substantive spring force.

While two elbow pegs 604 are shown, a single elbow peg 604 may be usedopposite a locking screw 106. This arrangement is not shown. In thiscase, the bone plate 602 would have an internally threaded hole 616 atone end (like hole 116 of bone plate 102) and at the other end, areceiver hole 628. The assembly would include a locking screw 106 in theinternally threaded hole 616 and an elbow peg 604 plus a screw in thereceiver hole 628.

In a further modification of assembly 600, a screw 108 and an elbow peg604 may be used together with no other apparatus. In this case, thescrew 108 and the leg 634 of the elbow peg 604 may lie on opposite sidesof the discontinuity between tissue portions. A screw 106 may also beused in this fashion, in which case the aperture 636 through the head632 of the elbow peg 604 preferably includes an internally threadedportion to engage the external threads 119 on the head 107 of the screw106.

Referring to FIGS. 7A-7F, an assembly 700 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 700,the stabilizing member may be a bone plate 702, the dynamic element maybe an elbow peg 704 also known as an L-peg, and the fasteners may be oneor more of the set screws 310.

The bone plate 702 has an obverse side 712 and a reverse side 714. Thebone plate 702 includes several holes 716, each of which may include aninternally threaded portion 718. The internally threaded portion 718 maybe adjacent to the obverse side 712. Each hole 716 may include aninterior shelf 723. The shelf 723 may be adjacent to the reverse side714. Two of the holes 716 are elongated toward each other, leaving a web724 extending between the two holes 716. The web 724 may be adjacent tothe reverse side 714. The web 724 separates the two holes 716, and maybe present even if the holes 716 are not elongated towards each other.The two elongated holes 716 and web 724 are referred to collectively asa receiver 726, and the involved holes 716 are referred to as receiverholes 728, since these features receive the elbow pegs 704.

Two elbow pegs 704 are shown facing each other in the assembly 700. Inthis example, the elbow pegs 704 take the place of the previous dynamicelement, the staple 104. Each elbow peg 704 includes a head 732 and abone-contacting leg 734, which terminates in a free end 735. The head732 may be rounded, as illustrated, or it may be any shape. The head 732may be perpendicular, or nearly perpendicular, to the leg 734. Forexample, the head 732 and the leg 734 may form an angle of 90 degrees±10 degrees, 90 degrees ±15 degrees, or 90 degrees ±20 degrees.Alternatively, the head 732 may form an acute angle or an obtuse anglewith the leg 734. Each elbow peg 704 may be independently inserted intoa bone hole and secured to the bone plate 702. The elbow peg 704 may besecured to the bone plate 702 by the set screw 310 against the head 734.The shelf 723 prevents the head 732 from passing through the reverseside 714 of the bone plate 702. The elbow peg 704 may develop somespring force as the set screw 310 is fully seated. FIG. 7D shows a freestate elbow peg 704 in the left hole. The head 732 and the leg 734 forman obtuse angle in the free state. A compressed elbow peg 704 is shownin the right hole. As a result of driving the set screw 310 tightlyagainst the head 732, the elbow peg 704 is elastically bent to a 90degree state, which is an elastically deformed state. The leg 734 exertsa force against the bone, acting toward the left-hand elbow peg 704. Theforce may be linear or nonlinear. A similar principle may apply to theelbow pegs 604 described for assembly 600. The elbow peg 704 may exertforce due to simple leverage without substantive spring force.

While two elbow pegs 704 are shown, a single elbow peg 704 may be usedopposite a locking screw 106. This arrangement is not shown. In thiscase, the bone plate would have an internally threaded hole 716 at oneend (like hole 116 of bone plate 102) and at the other end, a receiverhole 728. The assembly would include a locking screw 106 in theinternally threaded hole 716 and an elbow peg 704 plus a set screw 310in the receiver hole 728.

Referring to FIGS. 8A-8G, an assembly 800 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 800,the stabilizing member may be a bone plate 802, the dynamic element maybe a straight peg 804, and the fasteners may be one or more of the setscrews 310.

The bone plate 802 has an obverse side 812 and a reverse side 814. Thebone plate 802 includes several holes 816, each of which may include aninternally threaded portion 818. The internally threaded portion 818 maybe adjacent to the obverse side 812. Each hole 816 may include aninterior shelf 823. The shelf 823 may be adjacent to the reverse side814. A web 824 extends between two of the holes 816. The web 824 may beadjacent to the reverse side 814. The web 824 separates the two holes816, and may be present even if the holes 816 are elongated towards eachother. The two holes 816 are referred to as receiver holes 828, sincethese features receive the straight pegs 804.

Two straight pegs 804 are shown facing each other in the assembly 800.In this example, the straight pegs 804 take the place of the previousdynamic elements, the staple 104 or the elbow pegs 604, 704. Eachstraight peg 804 includes a head 832 and a bone-contacting leg 834,which terminates in a free end 835. The head 832 may be rounded, asillustrated, or it may be any shape. The head 832 may include a mark837, such as an arrowhead pointing toward the free end 835 of the leg834 (FIG. 8F). The head 832 may form an obtuse angle, a right angle, oran acute angle with the leg 834 (FIG. 8E). Each straight peg 804 may beindependently inserted into a bone hole and secured to the bone plate802. The straight peg 804 may be secured to the bone plate 802 by theset screw 310 against the head 832. The shelf 823 prevents the head 832from passing through the reverse side 814 of the bone plate 802. Thestraight peg 804 is free to rotate about its head 832 within thereceiver hole 828, at least until secured by the set screw 310.Alternatively, the straight peg 804 may be rotationally constrainedrelative to the receiver hole 828 to a set of discrete rotationalpositions. The head 832 and/or the leg 834 of the straight peg 804 maybe non-circular, and may engage a complementary non-circular portion ofthe receiver hole 828. A similar arrangement is illustrated in FIGS.25A-H. Whether the straight pegs 804 are free to rotate or constrainedto discrete rotational positions, the assembly 800 can deliver dynamicload in multiple directions relative to the bone plate 802 and/or otherstraight pegs 804. The mark 837 (arrowhead) may assist in orienting eachleg 834 in the desired direction. FIGS. 8D and 8E illustrate that thestraight peg 804 may develop spring force as the set screw 310 is fullyseated, according to the same principles described for assembly 700above. However, in FIG. 8E, the straight peg 804 is illustrated in itsfree state, having rotated counterclockwise due to the action of the setscrew 310. If the leg 834 were constrained to the position shown in FIG.8D, perpendicular to the bone plate 802, then the straight peg 804 woulddevelop spring force as the set screw 310 is tightened.

While two straight pegs 804 are shown, a single straight peg 804 may beused opposite a locking screw 106. This arrangement is not shown. Inthis case, the bone plate would have an internally threaded hole 816 atone end (like hole 116 of bone plate 102) and at the other end, areceiver hole 828. The assembly would include a locking screw 106 in theinternally threaded hole 816 and a straight peg 804 plus a set screw 310in the receiver hole 828.

Referring to FIGS. 24A-24J, an assembly 1000 may include a stabilizingmember and a dynamic element. In assembly 1000, the stabilizing membermay be the bone plate 602 and the dynamic element may be a straight peg1004.

Two straight pegs 1004 are shown facing each other in the assembly 1000.In this example, the straight pegs 1004 take the place of the previousdynamic elements, the staple 104 or the elbow pegs 604, 704 or thestraight peg 804. Each straight peg 1004 includes a rounded head 1032and a bone-contacting leg 1034, which terminates in a free end 1035. Thehead 1032 may form an obtuse angle, a right angle, or an acute anglewith the leg 1034 (FIG. 240). The head 1032 may include a mark pointingtoward the free end 1035 of the leg 1034, similar to mark 837 ofstraight peg 804. The leg 1034 may include external threads as shown, orthe leg 1034 may be smooth. Each straight peg 1004 may be independentlyinserted into a bone hole and secured to the bone plate 602. Thestraight peg 1004 may be secured to the bone plate 602 by threading theleg 1034 into bone, or with a set screw 310 as explained previously. Theshelf 623 prevents the head 1032 from passing through the reverse side614 of the bone plate 602. The straight peg 1004 may develop springforce, according to similar principles to those described above. FIG.24E illustrates an inserter tool 1040 for temporarily straightening theangle between the head 1032 and the leg 1034, and for threading the leg1034 into a bone hole. The inserter tool 1040 includes a torque drivefeature 1042 (a hex) with a distal shaft 1044 that extends within acannulation 1033 in the straight peg 1004.

While two straight pegs 1004 are shown, a single straight peg 1004 maybe used opposite a locking screw 106. This arrangement is not shown. Inthis case, the bone plate 602 would have an internally threaded hole 616at one end (like hole 116 of bone plate 102) and at the other end, areceiver hole 628. The assembly would include a locking screw 106 in theinternally threaded hole 616 and a straight peg 1004 in the receiverhole 628.

Referring to FIGS. 25A-25H, an assembly 1100 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 1100,the stabilizing member may be a bone plate 1102, the dynamic element maybe a wire peg 1104, and the fastener may include a set screw 310.

The bone plate 1102 has an obverse side 1112 and a reverse side 1114.The bone plate 1102 includes several holes 1116, each of which mayinclude an internally threaded portion 1118. The internally threadedportion 1118 may be adjacent to the obverse side 1112. Each hole 1116may include an interior shelf 1123. The shelf 1123 may be adjacent tothe reverse side 1114. A web 1124 extends between two of the holes 1116.The web 1124 may be adjacent to the reverse side 1114. The web 1124separates the two holes 1116, and may be present even if the holes 1116are elongated towards each other. The two holes 1116 are referred to asreceiver holes 1128, since these features receive the wire pegs 1104.Each receiver hole 1128 includes a noncircular through hole 1129. Theillustrated holes 1129 are rectangular, and may be square.

Two wire pegs 1104 are shown facing each other in the assembly 1100. Inthis example, the wire pegs 1104 take the place of the previous dynamicelements, the staple 114, the elbow pegs 604, 704, the straight pegs804, 1004. Each wire peg 1104 is formed from a sharply bent, or folded,piece of wire having a rectangular cross section. Each wire peg 1104includes a head 1132 and a bone-contacting leg 1134, which terminates ina free end 1135 where the wire is sharply bent or folded. The head 1132in this example is formed by outwardly bent ends, or terminal portions,of the wire. The head 1132 may form an obtuse angle, a right angle, oran acute angle with the leg 1134. In FIG. 25E-F, the outwardly bent wireends of the head 1132 form right angles with the leg 1134 when the wirepeg 1104 is in the free state. The outwardly bent wire ends of the head1132 are uneven when the wire peg 1104 is in the free state. Each wirepeg 1104 may be independently inserted into a bone hole and secured tothe bone plate 1102. The wire peg 1104 may be secured to the bone plate1102 with a set screw 310. The shelf 1123 prevents the head 1132 frompassing through the reverse side 1114 of the bone plate 1102. The wirepeg 1104 may develop spring force and may bow sideways as the set screw310 is tightened, due to the uneven height of the outwardly bent wireends of the head 1132. The stressed or bowed state of the wire peg 1104is illustrated in FIGS. 25A-25D, 25G, and 25H.

While two wire pegs 1104 are shown, a single wire peg 1104 may be usedopposite a locking screw 116. This arrangement is not shown. In thiscase, the bone plate would have an internally threaded hole 1116 at oneend (like hole 116 of bone plate 102) and at the other end, a receiverhole 1128. The assembly would include a locking screw 116 in theinternally threaded hole 1116 and a wire peg 1104 with a set screw 310in the receiver hole 1128.

Referring to FIGS. 26A-26H, an assembly 1200 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 1200,the stabilizing member may be a bone plate 1202, the dynamic element maybe a wire peg 1204, and the fastener may include a set screw 310.

The bone plate 1202 has an obverse side 1212 and a reverse side 1214.The bone plate 1202 includes several holes 1216, each of which mayinclude an internally threaded portion 1218. The internally threadedportion 1218 may be adjacent to the obverse side 1212. Each hole 1216may include an interior shelf 1223. The shelf 1223 may be adjacent tothe reverse side 1214. The shelf 1223 may include a medial alcove 1221.A web 1224 extends between two of the holes 1216. The web 1224 may beadjacent to the reverse side 1214. The web 1224 separates the two holes1216, and may be present even if the holes 1216 are elongated towardseach other. The two involved holes 1216 are referred to as receiverholes 1228, since these features receive the wire pegs 1204. Eachreceiver hole 1228 includes a noncircular through hole 1229. Theillustrated holes 1229 are elongated, and may be oval, round, or anothershape such as rectangular or square.

Two wire pegs 1204 are shown facing each other in the assembly 1200. Inthis example, the wire pegs 1204 take the place of the previous dynamicelements, the staple 104, the elbow pegs 604, 704, the straight pegs804, 1004, or the wire peg 1104. Each wire peg 1204 is formed from asharply bent, or folded, piece of wire having a round cross section.Each wire peg 1204 includes a head 1232 and a bone-contacting leg 1234,which terminates in a free end 1235 where the wire is sharply bent orfolded. The head 1232 in this example is formed by outwardly bent ends,or terminal portions, of the wire. The head 1232 may form an obtuseangle, a right angle, or an acute angle with the leg 1234. In FIG.26E-F, the outwardly bent wire ends of the head 1232 form right angleswith the leg 1234 when the wire peg is in the free state. The outwardlybent wire ends of the head 1232 are uneven when the wire peg is in thefree state. Each wire peg 1204 may be independently inserted into a bonehole and secured to the bone plate 1202. The wire peg 1204 may besecured to the bone plate 1202 with a set screw 310. The wire peg 1204may develop spring force and may bow sideways as the set screw istightened, due to the uneven height of the outwardly bent wire ends ofthe head 1232. The stressed or bowed state of the wire peg 1204 isillustrated in FIGS. 26A-26D, 26G, and 26H.

While two wire pegs 1204 are shown, a single wire peg 1204 may be usedopposite a locking screw 126. This arrangement is not shown. In thiscase, the bone plate would have an internally threaded hole 1216 at oneend (like hole 116 of bone plate 102) and at the other end, a receiverhole 1228. The assembly would include a locking screw 126 in theinternally threaded hole 1216 and a wire peg 1204 with a set screw 310in the receiver hole 1228.

Referring to FIGS. 27A and 27B, an alternative wire peg 1302 is formedfrom a sharply bent, or folded, piece of wire having a round crosssection. Each wire peg 1304 includes a head 1332 and a bone-contactingleg 1334, which terminates in a free end 1335 where the wire is sharplybent or folded. The head 1332 in this example is formed by an outwardlybent end, or terminal portion, of the wire and a straight end of thewire. The head 1332 may form an obtuse angle, a right angle, or an acuteangle with the leg 1334. In FIG. 26E-F, the outwardly bent wire end ofthe head 1332 forms a right angle with the leg 1334 when the wire peg isin the free state. The outwardly bent wire end of the head 1332 isuneven with the straight end of the head 1332 when the wire peg is inthe free state. This wire peg 1302 may be used interchangeably with thewire pegs 1102 and 1202.

Referring to FIGS. 28A-28F, an assembly 1400 may include a stabilizingmember, a dynamic element, and one or more fasteners. In assembly 1400,the stabilizing member may be a bone plate 1402, the dynamic element maybe a staple 1404, and the fasteners may be screws. Assembly 1400 isillustrated with locking screws 1406 on the left and non-locking screws1408 on the right.

The bone plate 1402 has an obverse side 1412 and a reverse side 1414.The bone plate 1402 includes several holes 1416 which extend through theobverse and reverse sides 1412, 1414. Sixteen holes 1416 areillustrated, although any number of holes may be present. Each hole 1416includes an internally threaded portion 1418 and a non-threaded portion1420 so that each hole 1416 accepts either the locking screw 1406 or thenon-locking screw 1408. The internally threaded portion 1418 engagesexternal threads 1419 on the head 1407 of the locking screw 1406. Theinternally threaded portion 1418 may be adjacent to the reverse side1414. The non-threaded portion 1420 engages the head 1409 of thenon-locking screw 1408. The non-threaded portion 1420 may be adjacent tothe obverse side 1412. The non-threaded portion 1420 may be concaveand/or elongated. An optional groove 1422 in the obverse side 1412extends along a line of six holes 1416 that extend along the midline ofthe plate 1402. Each of these six holes 1416 is also elongated, leavingwebs 1424 extending between the second and third holes 1416 and thefourth and fifth holes 1416. No webs are shown between the first andsecond holes 1416, the third and fourth holes 1416, or the fifth andsixth holes 1416, although these webs may be present. The webs 1424 maybe adjacent to the reverse side 1414. The webs 1424 separate the secondand third holes 1416 and the fourth and fifth holes 1416, respectively,and may be present even if the holes 14416 are not elongated. The firstand second holes 1416 are referred to collectively as a receiver 1426,and the involved holes 1416 are referred to as receiver holes 1428. Asecond receiver 1426 includes the third and fourth holes 1416, and athird receiver 1426 includes the fifth and sixth holes 1416.

The staple 1404 is described in at least one of the patent applicationsidentified in paragraph [0001] of this application. The staple 1404 maybe the implant 200 of FIGS. 11 and 12, implant 300 of FIGS. 15A-16B,implant 600 of FIGS. 21 and 22, implant 800 of FIGS. 23A-24, or implant2200 of FIGS. 78 and 79 of International Patent Application Serial No.PCT/US2015/039551; or implant 100 of FIGS. 1-3, staple 300 of FIGS. 4and 5, staple 400 of FIG. 7, staple 480 of FIG. 8, or implant 2100 ofFIGS. 10A and 10B of International Patent Application Serial No.PCT/US2015/039556. The illustrated staple 1404 is the implant 2200 ofFIGS. 78 and 79 of International Patent Application Serial No.PCT/US2015/039551.

The staple 1404 includes a body 1440 or bridge, a first leg 1442, and asecond leg 1444. The bridge extends between a first end 1446 and asecond end 1448. The first leg 1442 is coupled to the first end 1446 andterminates in a first free end 1443. The second leg 1444 extends fromthe second end 1448 and terminates in a second free end 1445. A firstprojection 1450 extends from the first end 1446 and a second projection1452 extends from the second end 1448.

The staple 1404 has an insertion state, or elastically deformed state,which is its shape under the influence of an external force, forexample, an external force applied by a staple inserter tool. A firstdistance separates the free ends 1443, 1445 in the elastically deformedstate. The staple 1404 also has a free state, or relaxed state, which isits shape when no external forces are acting upon the staple, other thangravity. A second distance separates the free ends 1443, 1445 in therelaxed state. The second distance is different from the first distance.In the example shown, the legs 1442, 1444 of the staple 1404 areparallel to one another in the elastically deformed state. However, thelegs 1442, 1444 may converge or diverge in the elastically deformedstate. In the example shown, the legs 1442, 1444 of the staple convergeat their free ends 1443, 1445, or tips, in the relaxed state, so thatthe second distance is less than the first distance. However, the legs1442, 1444 may diverge at their free ends 1443, 1445, or the legs 1442,1444 may be parallel in the relaxed state. The staple 1404 assumes theelastically deformed state under the influence of an external force. Thestaple 1404 may resume the free state as soon as the external force isremoved. If the legs 1442, 1444 of the staple 1404 are engaged in boneholes, then the staple may only be able to partially relax toward thefree state due to the resistance of the bone. In this situation, thestaple 1404 may be in a loaded state in between the elastically deformedstate and the relaxed state. In this example, the staple 1404 is notlocked to the bone plate 1402, although in other examples the staple islocked to the bone plate. In this example, the body 1440 of the staple1404 rests within the receiver 1426, and the staple legs 1442, 1444extend through the receiver holes 1428 and protrude from the reverseside 1414 of the bone plate 1402. The receiver 1426 holds the staple1404 in a predetermined orientation and relative position with respectto the bone plate 1402. The receiver 1426 is one example of a group offeatures that function together to hold a staple a in a predeterminedorientation and relative position with respect to a bone plate.Different features, or groups of features, may provide the samefunction. For example, the body 1440 of the staple 1404 may rest atopthe obverse side 1412 of the bone plate 1402, or on a web, or the web1424 may be replaced by ledges or other supports to serve as a stop or adocking point to prevent the body 1440 from passing through the reverseside 1414. Furthermore, the web 1424 may be replaced by one or more stopfeature(s) or docking feature(s) on the staple 1404 instead of on thebone plate 1402. For example, the projections 1450, 1452 may serve asstop features or docking features.

The locking screw 1406 locks securely to any hole 1416 in the bone plate1402. The locking screw 1406 may include an externally threaded head1407 which locks to the hole 1416 in the bone plate 1402 when threadedtightly into the internally threaded portion 1418 of the hole 1416. Thelocking screw 1406 may be the design disclosed in at least one of thepatent applications identified in paragraph [0001] of this application.The locking screw 1406 may be the bone fixation device 390 of FIG. 11,bone fixation device 500 of FIGS. 24-26, bone fixation device 600 ofFIGS. 27-30 of International Patent Application Serial No.PCT/US2014/070495.

The non-locking screw 1408 does not lock to the holes 1416 in the boneplate 1402. Instead, it remains free to rotate and translate within theconfines of the screw hole 1416 after implantation. The non-lockingscrew 1408 may be polyaxially positionable relative to the screw hole1416. The non-locking screw 1408 may include a head 1409 with anexterior surface that forms a ball-and-socket joint with thenon-threaded portion 1420 of the hole 1416. The exterior surface may beconvex, spherical, or conical.

The screws 1406 and 1408 are interchangeable in the screw holes 1416 ofthe bone plate 1402.

Referring to FIGS. 9A and 9B, a normal human foot 10 includes twenty-sixbones, including a talus 12, a calcaneus 14, a navicular 16, a medialcuneiform 18, an intermediate cuneiform 20, a lateral cuneiform 22, acuboid 24, a first metatarsal 26, a second metatarsal 28, a thirdmetatarsal 30, a fourth metatarsal 32, a fifth metatarsal 34, a firstproximal phalanx 36, a second proximal phalanx 38, a third proximalphalanx 40, a fourth proximal phalanx 42, a fifth proximal phalanx 44, afirst middle phalanx 46, a second middle phalanx 48, a third middlephalanx 50, a fourth middle phalanx 52, a first distal phalanx 54, asecond distal phalanx 56, a third distal phalanx 58, a fourth distalphalanx 60, and a fifth distal phalanx 62.

Referring to FIG. 14, several different surgical instruments may beprovided in a kit or a set. From top to bottom, left to right, FIG. 14illustrates a plate template, a threaded drill guide/ depth gage, apolyaxial drill guide/depth gage, a bender/handle, a staple drill guide,an olive wire, drills (such as 2.0 mm and 2.5 mm diameters), and aself-retaining screwdriver (not shown) and a screwdriver handle, such asan AO quick connect handle (not shown).

Referring to FIG. 15, a plate sizing template may include severalindividual templates for different plate shapes, each of which may beremoved from, or “punched out” of, or torn away from the sizingtemplate. The template may be provided sterile. Templating may be a stepin a method for using the disclosed apparatus.

Referring to FIGS. 16A, 16B, and 17A-17C, a plate bender may include athreaded end and a forked end opposite the threaded end. The threadedend threads into the plate holes, as shown in FIGS. 17B and 17C. Theforked end receives the plate, as shown in FIGS. 16A and 17A. The platebender may also be used as a handle for the non-locking polyaxial drillguide (FIG. 20). Multiple plate benders may be provided in a kit or setof instruments. The plate bender(s) may be provided sterile. Platebending or plate contouring may be a step in a method for using thedisclosed apparatus. Plates may be bent in-situ or on a back table in anoperating room.

Referring to FIG. 18, a threaded drill guide may lock into a threadedhole in a bone plate, for example bone plate 902, to accurately guide adrill to make a hole in the bone to receive a locking screw 106. Thethreaded drill guide may also be used as a bone plate inserterinstrument. Multiple threaded drill guides may be included in a kit orset of instruments. Inserting a bone plate may be a step in a method forusing the disclosed apparatus.

Referring to FIGS. 19A and 19B, an olive wire may be used for temporaryfixation in a hole in a bone plate, for example bone plate 902. A lasermark on a drill may register with drill guide depth markings to indicatedrilling depth (FIG. 19A). Drilling for a locking bone screw, and/ortapping for the locking bone screw, may be steps in a method for usingthe disclosed apparatus.

Referring to FIGS. 20A and 20B, a non-locking polyaxial drill guide mayengage a hole in a bone plate, for example bone plate 902, to accuratelyguide a drill to make a hole in the bone to receive a non-locking screw108. The plate bender may serve as a handle for the non-lockingpolyaxial drill guide (FIG. 20A). Drilling for a non-locking bone screw,and/or tapping for the non-locking bone screw, may be steps in a methodfor using the disclosed apparatus.

Referring to FIG. 21, locking or non-locking screws may be usedinterchangeably in the screw holes of the bone plates after bone holesare drilled. A screw driver instrument transmits torque from a manual orpower source to the screw to drive the screw into the bone and, if alocking screw, into the screw hole threads of the bone plate. While FIG.21 shows locking screws 106 placed proximally, but the procedure mayprogress from distal to proximal instead. Driving a screw into threadedengagement with the bone and, if a locking screw, with the screw holethreads of the bone plate, may be a step in a method for using thedisclosed apparatus.

Referring to FIGS. 22A-22C, a staple drill guide may engage a pair ofholes in a bone plate, for example bone plate 902, to accurately guide adrill to make holes in the bone to receive a staple 104. Drilling for astaple may be a step in a method for using the disclosed apparatus. Thestep of drilling for the staple may occur after one end (proximal ordistal) of the plate is secured to bone.

A staple inserter may hold the staple 104 for insertion (FIG. 22B). Thestaple inserter is described in at least one of the cross-referencedpatent applications identified in paragraph [0001] of this application.For example, the staple 104 may be held with its legs forced into aparallel state for insertion. The staple inserter may engage the staple104 strictly from a side of the staple opposite the side that faces thebone plate and bone portions, so that the staple 104 may be fully seatedin the receiver while the staple inserter is attached to the staple 104.After the staple has been inserted through the bone plate, removing thestaple inserter may allow the staple legs to relax and attempt to resumethe free state, in which the staple legs are acutely angled with respectto each other (FIGS. 1A-1F). Inserting a staple may be a step in amethod for using the disclosed apparatus.

FIG. 22C shows the bone plate 902 and the staple 104 extending acrossthe first Lisfranc joint (or first tarsometatarsal joint) of a humanleft foot. The staple extends through holes in the bone plate 902 sothat each staple leg is on a different side of the joint. As the staplerelaxes after the staple inserter is removed, the staple legs applymechanical load or stress across the joint. As the staple 104 relaxestowards its free state shown in FIGS. 1A-1F, the staple legs applycompressive load or stress across the joint. Conversely, a staple withdivergent legs would apply tensile load or stress across the joint.

Referring to FIG. 23, the bone plate 902, staple 104, locking screws106, and non-locking screws 108 are shown in the final implanted stateacross the first Lisfranc joint. It may be particularly advantageous touse locking screws 106 adjacent to one leg of the staple 104, andnon-locking screws 108 adjacent to the other leg of the staple 104. Thisis illustrated in FIG. 23, where locking screws 106 are used in themedial cuneiform 18 and non-locking screws 108 are used in the firstmetatarsal 26. However, an opposite arrangement is contemplated, withnon-locking screws 108 are used in the medial cuneiform 18 and lockingscrews 106 are used in the first metatarsal 26.

Methods of using the disclosed apparatus may include any combination ofthe above mentioned steps, in any order.

One example of a method of using the disclosed apparatus includes thesteps of: inserting a bone plate adjacent to a first bone portion and asecond bone portion, wherein a discontinuity separates the second boneportion from the first bone portion, wherein the bone plate extendsacross the discontinuity, wherein the bone plate includes at least fourholes; locking a threaded drill guide to a first hole through the boneplate, wherein the first hole of the bone plate is adjacent to the firstbone portion; drilling a first bone hole through the threaded drillguide into the first bone portion; driving a locking screw through thefirst hole of the bone plate into threaded engagement with the firstbone hole and the first hole of the bone plate; engaging a staple drillguide with a second hole through the bone plate and a third hole throughthe bone plate, wherein the second hole of the bone plate is adjacent tothe first bone portion, wherein the third hole of the bone plate isadjacent to the second bone portion; drilling a second bone hole throughthe staple drill guide into the first bone portion; drilling a thirdbone hole through the staple drill guide into the second bone portion;inserting a first leg of a staple through the second hole of the boneplate into engagement with the second bone hole and inserting a secondleg of the staple through the third hole of the bone plate intoengagement with the third bone hole, wherein the first leg of the stapleis parallel to the second leg of the staple while the staple isinserted, wherein the first and second legs of the staple compresstowards each other after the staple is inserted; engaging a non-lockingpolyaxial drill guide with a fourth hole through the bone plate, whereinthe fourth hole of the bone plate is adjacent to the second boneportion; drilling a fourth bone hole through the non-locking polyaxialdrill guide into the second bone portion; and driving a non-lockingscrew through the fourth hole of the bone plate into threaded engagementwith the fourth bone hole and non-locking engagement with the fourthhole of the bone plate.

The preceding method may also include the step of securing the staple tothe bone plate. The staple may be secured to the bone plate with a setscrew, a ductile tab, or a snap fit. The staple may be secured to thebone plate by a portion of the staple being molded within a portion ofthe bone plate. The staple may be secured to the bone plate by beingintegrally formed with the bone plate.

Another example of a method of using the disclosed apparatus includesthe steps of: inserting a bone plate adjacent to a first bone portionand a second bone portion, wherein a discontinuity separates the secondbone portion from the first bone portion, wherein the bone plate extendsacross the discontinuity; drilling a first bone hole through a firsthole through the bone plate into the first bone portion; drilling asecond bone hole through a second hole through the bone plate into thesecond bone portion; inserting a leg of a first elbow peg through thefirst hole of the bone plate into engagement with the first bone holeand placing a head of the first elbow peg adjacent to the first hole ofthe bone plate; inserting a leg of a second elbow peg through the secondhole of the bone plate into engagement with the second bone hole andplacing a head of the second elbow peg adjacent to the second hole ofthe bone plate; driving a first bone screw through an aperture throughthe head of the first elbow peg and the first hole of the bone plateinto threaded engagement with the first bone portion beside the leg ofthe first elbow peg; and driving a second bone screw through an aperturethrough the head of the second elbow peg and the second hole of the boneplate into threaded engagement with the second bone portion beside theleg of the second elbow peg.

Yet another example of a method of using the disclosed apparatusincludes the steps of: inserting a bone plate adjacent to a first boneportion and a second bone portion, wherein a discontinuity separates thesecond bone portion from the first bone portion, wherein the bone plateextends across the discontinuity; drilling a first bone hole through afirst hole through the bone plate into the first bone portion; drillinga second bone hole through a second hole through the bone plate into thesecond bone portion; inserting a leg of a first elbow peg through thefirst hole of the bone plate into engagement with the first bone holeand placing a head of the first elbow peg over the first hole of thebone plate; inserting a leg of a second elbow peg through the secondhole of the bone plate into engagement with the second bone hole andplacing a head of the second elbow peg over the second hole of the boneplate; tightening a first set screw against the head of the first elbowpeg; and tightening a second set screw against the head of the secondelbow peg.

Yet another example of a method of using the disclosed apparatusincludes the steps of: inserting a bone plate adjacent to a first boneportion and a second bone portion, wherein a discontinuity separates thesecond bone portion from the first bone portion, wherein the bone plateextends across the discontinuity; drilling a first bone hole through afirst hole through the bone plate into the first bone portion; drillinga second bone hole through a second hole through the bone plate into thesecond bone portion; inserting a leg of a first straight peg through thefirst hole of the bone plate into engagement with the first bone holeand placing a head of the first straight peg in the first hole of thebone plate; inserting a leg of a second straight peg through the secondhole of the bone plate into engagement with the second bone hole andplacing a head of the second straight peg in the second hole of the boneplate; tightening a first set screw against the head of the firststraight peg; and tightening a second set screw against the head of thesecond straight peg.

The preceding method may also include the step of rotating the firstand/or second straight pegs to position the leg(s) in desiredorientation(s) relative to the bone plate before tightening the setscrews.

Any methods disclosed herein includes one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, Figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.Thus, the claims following this Detailed Description are herebyexpressly incorporated into this Detailed Description, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. Elements recited inmeans-plus-function format are intended to be construed in accordancewith 35 U.S.C. § 112 Para. 6. It will be apparent to those having skillin the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the technology.

While specific embodiments and applications of the present technologyhave been illustrated and described, it is to be understood that thetechnology is not limited to the precise configuration and componentsdisclosed herein. Various modifications, changes, and variations whichwill be apparent to those skilled in the art may be made in thearrangement, operation, and details of the methods and systems of thepresent technology disclosed herein without departing from the spiritand scope of the technology.

What is claimed is:
 1. A bone fixation system, comprising: a bonefixation device comprising: a stabilizing body comprising: an obverseside; a reverse side opposite the obverse side; and a plurality offastener openings extending through the obverse side and the reverseside; and a first leg integrally formed with the stabilizing body andextending from the reverse side of the stabilizing body to a first freeend; and a second leg integrally formed with the stabilizing body andextending from the reverse side of the stabilizing body to a second freeend; wherein the first free end is separated from the second free end bya first distance when bone fixation device is in an elastically deformedstate; wherein the first free end is separated from the second free endby a second distance when the bone fixation device is in a relaxedstate, the first distance being different than the second distance suchthat the bone fixation device provides a force at the first and secondfree ends when the bone fixation devices is in an elastically deformedstate; and a plurality of fasteners configured to be positioned withinthe one or more fasteners openings of the stabilizing body and to extendthrough the stabilizing body.
 2. The bone fixation system of claim 1,wherein the first distance is greater than the second distance such thatthe bone fixation device provides a compressive force between the firstand second free ends when the bone fixation devices is in an elasticallydeformed state.
 3. The bone fixation system of claim 1, wherein at leasta portion of the bone fixation device is formed of a superelasticmaterial.
 4. The bone fixation system of claim 3, wherein at least aportion of the bone fixation device is formed of nitinol.
 5. The bonefixation system of claim 1, wherein at least a portion of thestabilizing body between the first leg and the second leg is configuredto deform when the bone fixation device transitions from the elasticallydeformed state to the relaxed state.
 6. The bone fixation system ofclaim 1, wherein the plurality of fasteners comprises a plurality ofbone screws.
 7. The bone fixation system of claim 1, wherein theplurality of fasteners are configured to rotate and translate within theplurality of fastener openings.
 8. The bone fixation system, wherein theplurality of fasteners are polyaxially positionable relative to theplurality of fastener openings.
 9. The system of claim 1, wherein theplurality of fastener openings comprise a first fastener opening and asecond fastener opening.
 10. The system of claim 9, wherein the firstleg extends from the stabilizing body at a first location and the secondleg extends from the stabilizing body at a second location, the firstlocation being separated from the second location by a third distance;and wherein the first fastener opening is separated from the secondfastener opening by a fourth distance, the fourth distance being greaterthan the third distance.
 11. The system of claim 9, wherein the firstfastener opening and the second fastener opening are positioned along alongitudinal axis of the stabilizing body.
 12. The system of claim 11,wherein the first leg extends from the stabilizing body at a positionbetween the first fastener opening and the second fastener openingrelative to the longitudinal axis.
 13. The system of claim 12, whereinthe second leg extends from the stabilizing body at a position betweenthe first fastener opening and the second fastener opening relative tothe longitudinal axis.
 14. The system of claim 13, wherein first leg andthe second leg extend from the stabilizing body along the longitudinalaxis.
 15. The system of claim 9, wherein at least one of the firstfastener opening and the second fastener opening is positioned lateralto a longitudinal axis of the stabilizing body.
 16. The system of claim9, further comprising a third fastener opening.
 17. The system of claim1, wherein the first leg and the second leg are substantially parallelin the elastically deformed state.
 18. The system of claim 1, whereinthe stabilizing body comprises a bone plate.
 19. The system of claim 18,wherein the first leg and the second leg are part of a staple integrallyformed with the bone plate.
 20. The system of 19, wherein the staplecomprises a bridge extending between the first leg and the second leg.